Medeva pertussis vaccines fail the Art 3 test as question of appeal remains unresolved

On Monday, in Medeva BV's application, BL O/357/09, Dr Lawrence Cullen was faced with five applications for supplementary protection certificates (SPCs), each of which was based on the same patent, EP (UK) 1 666 057 B1, which was filed on 20 April 1990 with a priority date of 8 May 1989, then granted on 18 February 2009.

The SPCs covered pertussis vaccines, each of which contained the two active ingredients expressly covered by the basic patent, in combination with several other active ingredients [there's a neat tabular representation of the combinations at p.2 of the decision]. Dr Cullen upheld the examiner's view that the basic patent could not be construed as protecting any combination of this type and that an application for an SPC covering only the two claimed active ingredients could not succeed because there was no marketing authorisation for such a product; all the authorisations were for combined products [these are neatly tabulated on p.3]. Since the defects in the application had not been remedied by Medeva within the four-month window for rectifying them, the applications were doomed.

At paragraphs 12 to 13 Dr Cullen mentions a preliminary issue, which remains outstanding since his decision dealt only with the substantive question of whether the applications fulfilled the requirements of Article 3 of Regulation 469/2009:

"12. In correspondence with the examiner, the applicant gave notice that they
considered his report dated 31 July 2009 to be a ‘final decision’ on these
applications and, as a consequence, that they would bring this ‘final decision’ to
refuse these SPC applications as an appeal before the Patent Court. The
examiner wrote back on 1 September 2009 indicating that this examination report
did not constitute a final decision, that a response to the examination report was
awaited and that, if the applicant did not have further arguments or observations
on these applications, they could request a final decision on these applications
from the Office, either at an oral hearing, or if they wished to expedite matters, on
the basis of the papers currently on file. The applicant replied on 9 September
2009 waiving their right to be heard and indicating that they would like a decision
based on the papers currently on file so that the status of these applications
could be resolved before expiry of the basic patent in April 2010.

13. However, this request was made without prejudice to the ongoing question over
whether or not it is appropriate to launch an appeal based on an examination
report. While the Office agreed to the applicant's request for a decision from the
papers, it also indicated that it would reserve its right to seek an order to have
this appeal application struck out on the ground that there was no decision of the
Office to appeal from at that date".